Research Integrity Specialist
About The Position
The Research Integrity Specialist ensures compliance with federal FDA and NIH regulations throughout the review and approval process for research protocols involving human subjects. The position manages IRB review and approval activities, provides guidance to researchers on submissions and protocol-related deficiencies, reviews qualifying protocols independently, maintains the IRB database, and supports compliance with regulatory requirements and institutional policies. The role also requires adherence to the company’s ethical and legal standards, Code of Business Conduct, HIPAA requirements, privacy policies, and information security guidelines. Employees may have access to covered information, cardholder data, or other confidential customer information and must protect it.
Requirements
- Bachelor’s degree in Health Sciences or a related field, or relevant experience and/or education as determined by the company in lieu of a bachelor’s degree.
- Three years of recent IRB or clinical research coordinator experience.
Nice To Haves
- CIM or CRC.
- Certified IRB Professional (CIP).
- Certified IRB Manager.
Responsibilities
- Plan and manage activities related to IRB review and approval of research protocols involving human subjects submitted by researchers.
- Guide researchers on protocol submissions and correction of medical and technical deficiencies, informed consent documents, amendments, and related matters.
- Independently review submitted protocols for exempt or expedited review based on clinical expertise and training.
- Maintain the IRB database.
- Maintain compliance with regulatory agencies, institutional policies, procedures, guidelines, and federal regulations.
- Protect covered information, cardholder data, and confidential customer information and comply with HIPAA, privacy policies, information security guidelines, the Code of Business Conduct, and applicable laws and policies.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
